Quality Assurance Auditor II

Location

Rockville, MD | United States

Job description

Quality Assurance Specialist

The Quality Assurance Unit independently audits regulated studies under the direction of QA leadership and in line with the GLPs and relevant SOPs approved by management. The QAU will verify adherence to standard operating procedures (SOPs), protocols, and applicable government regulations, and report findings to Management and other appropriate parties as defined by applicable government regulations and company policy. Members of the QAU will also communicate and collaborate with leadership and staff involved in the conduct of nonclinical laboratory studies to support understanding of the regulations.

Corporate Responsibilities:

• Adherence to laboratory health and safety procedures
• Adherence to Standard Operating Procedures (SOPs)
• Adherence to applicable company policies and guidelines
• Adherence to federal and/or local regulations as applicable

Essential Position Responsibilities:

• Work independently. Must do own work as well as other responsibilities with minimal daily oversight.
• Advanced knowledge of regulatory framework and interpretation of regulations.
• Understand business needs from multiple points of view and provides suggestions to address current issues while also maintaining a long-term solution.
• Working knowledge of business-related processes/procedures terminology and compliance.
• Ability to comprehend and apply applicable government regulations.
• Analytical thinker with the ability to understand problems, determine root cause and recommend appropriate solutions.
• Excellent verbal and written communication skills; must be able to relay complex concepts in a concise and easy to understand manner.
• Ability to prioritize and handle multiple projects, often under tight time constraints.
• Effectively work with peers, leadership, and stakeholders in a productive collaborative environment.
• Ability to understand and comply with confidentiality and privacy rules and protect company property and confidential information.
• Experience in Good Laboratory Practice (GLP)

Additional Position Responsibilities

• May develop and review new procedures, technologies, and SOPs as required.
• Hosts external audits with minimal support from QA Manager.
• Assists in responding to Requests for Information (RFIs) and external audit observations.
• Reviews computer system validation and change control documents.
• Independently conduct internal facility inspections for compliance with GLPs and SOPs.
• Participate in departmental business, process, or general regulatory projects.
• Participate in or lead subcontractor or vendor evaluation.
• Conduct quality training for new hires, as assigned.
• Ensure timely archival of all QA records.
• Attend pre-initiation/pre-planning meetings to represent QA team as well as serving as a resource for compliance discussions, as assigned.
• Assists with maintenance of Quality metrics and works closely with the Quality Manager to review KPIs of team performance and identify opportunities for training and process improvements.
• Schedules day to day assignments for team as directed by manager.
• Interacts closely with Operations Management and Study Direction to ensure on time delivery of assignments and to resolve issues quickly under collaboration.
• Other duties as assigned.

Additional Requirements:

• Demonstrate solid understanding of application and interpretation of FDA and EPA GLPs as well as applicable international regulations.
• Keep abreast of new rules, guidance, and industry standards to improve laboratory compliance.
• Experience working with Laboratory Information Management Systems (LIMS) such as Watson, Rees, or FCS Express (preferred)
• Understanding of Bioanalytical/Biotherapeutic analysis in the fields of PK, ADA, Biomarker, Genomics, or Flow Cytometry analysis
• Familiar with concepts and strategies for risk based analysis and process improvements.  

Working Conditions & Physical Requirements

• Work requires passing a physical and the use of other PPE (personal protective equipment)
• Ability to push, pull, lift 25 pounds unassisted.
• Stand / walk for extended period of time.
• Sit and work at a computer for extended period of time.
• Fine manipulation including handle touch object or tools and ability to handled controls to perform work.
• Ability to read and interpret materials, verbally communicate, and hear required.

Professional Responsibilities: (if applicable)

• Maintain an active involvement in professional organizations.
• Be knowledgeable in regulatory requirements.

• Minimum of a BS/BA in a scientific discipline, Master’s preferred or equivalent combination of education and experience .
• RQAP -GLP or CQA certification preferred.
• 5+ years of experience auditing or working in a GLP facility or a combination thereof. Experience with quality systems management and enterprise quality management software. Preference given to relevant work experience.
• Proficiency in basic computer applications such as email, MS Word, and Excel.
• Effective oral and written communication skills.
• Able to work independently.

*This position could be offered at different levels for candidates who qualify with a combination of advanced levels of education and/or years of experience. The salary range will adjust along with the level of the role to match the person’s relevant experience and/or education level.

Inotiv is a growing contemporary drug discovery and development company where we “Play to Win” in an industry rich with opportunity. Together, we face challenges and together we win in the delivery of world-class drug discovery and development solutions that impact the health and well-being of people all over the world. There’s an opportunity for everyone at all phases of a career, each individual’s unique skill set has an impact on the work we conduct. If you have the talent and desire to impact the quality of people’s lives, we have the career opportunities to make it happen. Join us in embracing research and science to impact the health and well-being of people all over the world.

Inotiv has been named a 2023 Top Workplace!

Salary will be commensurate with experience and responsibilities. Benefits include health and dental coverage, short- and long-term disability, paid time off, paid parental leave, 401K participation with company match, and more!

Inotiv is an Equal Opportunity Employer. It is our policy to provide a fair and equal employment opportunity to all persons, regardless of age, race, color, religion, sex, gender, gender identity, gender expression, sexual orientation, genetic information, disability, national origin, veteran status, or any other basis prohibited by law. This policy governs all aspects of employment, including selection, job assignment, compensation, discipline, termination and access to benefits and training.

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